Sorafenib in Elderly mRCC

NCT01728948 | Completed

• 2 other identifiers: 16399NX1212CN
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, single arm, multi-center pilot study includes 120 mRCC patients over 65 years, no prior systemic treatment, determined to be candidates for systemic therapy by the investigator. The treatment with Sorafenib should comply with the recommendations written in the local product information. The primary endpoint is overall survival. The secondary endpoints including other effectiveness points, safety and patients characteristics. With 120 completed patients, if the observed survival rate at 12 months is 60%, the width of a 95% confidence interval will be approximately 18%.

Conditions

Carcinoma, Renal Cell

Keywords

Sorafenib; renal cell carcinoma(RCC); elderly; effectiveness; safety

Outcome Measures

Primary Outcomes (1)

• Overall survival

  up to 2.5 years

Secondary Outcomes (8)

• Progression free survival by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria

  up to 2.5 years

• Disease control rate by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria

  up to 2.5 years

• Survival rate by one year

  up to 1 year

• Number of participants with adverse events (AE) and Serious adverse events (SAE) as a measure of safety and tolerability

  up to 3.5 years

• Patient characteristics (birthdate (at least year), sex, weight, height, etc)

  up to 2.5 years

Study Arms (1)

Group 1

Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

Sorafenib (Nexavar, BAY43-9006) DRUG

treatment (including dose, duration, modification) decided by the investigator

Group 1

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

mRCC patients, \>= 65 years of age, No prior systemic treatment, need systemic therapy

You may qualify if:

• Patients with histologically/cytologically diagnosed metastasis RCC who are candidates for systemic therapy and have decided to accept Sorafenib treatment.
• \>=65 years of age
• Patients who have signed the informed consent
• Patients with a life expectancy of ≥12 weeks
• No prior systemic treatment

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 20, 2012
• Study Start: January 6, 2013
• Primary Completion: January 4, 2016
• Study Completion: January 16, 2017
• Last Updated: November 9, 2017

Record last verified: 2017-11

Locations

CN (1)